Subcutaneous Infusion Set With Side Port Fluid Connector
An infusion set preferably for use with an inserter is disclosed. The infusion set includes a septum cap that encapsulates an upper resilient septum and a lower resilient septum of a base, and includes at least one radial port to receive insertion of a blunt cannula when an extension set hub is engaged with the infusion set in a direction substantially parallel to the skin surface. The extension set hub is configured to provide a snap-fit engagement with the septum cap, wherein the blunt cannula of the extension set hub is guided through the radial port of the septum cap and penetrates the interface between the upper septum and the lower septum. The extension set hub and the septum cap can be rotated in a 360 degree manner about the base of the infusion set.
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This application claims the benefit under 35 U.S.C. §119(e) of a U.S. provisional patent application of Ralph L. Sonderegger entitled “Subcutaneous Infusion Set Using Side Port”, Ser. No. 61/677,829, filed on Jul. 31, 2012, the entire content of said application being incorporated herein by reference.
FIELD OF THE INVENTIONThe present invention relates generally to a subcutaneous infusion set having a side port fluid connector. The infusion set can be inserted and attached to the skin using commercially available inserter devices.
BACKGROUND OF THE INVENTIONOne mode of insulin infusion treatment includes infusion pump therapy provided via a catheter, needle or other type of cannula incorporated into an infusion set. Infusion pumps offer the advantages of controllable and/or continuous infusion of insulin, precision dosing, and programmable delivery schedules as desired by the user or required by the application. Together, these advantages result in a number of benefits, such as more accurate blood glucose control. In this mode of insulin infusion treatment, the infusion pump remains attached to the user and the required doses of insulin are delivered to the user via the catheter, needle or other type of cannula incorporated into the infusion set.
One type of cannula incorporated into an infusion set for performing such treatments is a catheter, which generally is a flexible tube that can be inserted into the body to permit the administration of fluids to a targeted location. In infusion pump therapy, the types and sizes of the catheter may vary, but generally, the catheter is a thin, flexible tube with one or more openings to permit fluid communication. In some uses, however, the catheter can comprise a larger diameter and/or length, and can be constructed of rigid material or a combination of rigid and flexible materials.
One type of conventional infusion set is sold as the Quick-Set® infusion set manufactured by Medtronic. In this device, a catheter assembly is provided which is connected to an infusion pump via a tube set, and an insertion device is used to insert or attach the catheter assembly to a user. The infusion set and insertion device can also be combined or integrated, as in the Mio® infusion set manufactured by Medtronic, which is an “all-in-one” design that combines the infusion set and insertion device into a single unit.
Catheter infusion sets are often complex in design and do not provide a quick or simple method for fully priming the infusion set prior to subcutaneous injection of medicaments. Further, catheter infusion sets are often bulky and indiscreet when used under the clothing of a user. Catheter infusion sets can also be uncomfortable due to the torque placed upon the needle injection site from a rigid placement of the infusion set and tubing in relation to the infusion pump.
Accordingly, a need exists for an improved infusion set design and construction that will reduce construction costs and provide for mobility and comfort for the user while allowing discreet wearability of the infusion set and pump.
SUMMARY OF THE INVENTIONAn object of the present invention is to substantially address the above and other concerns, and provide an infusion set that is simple to manufacture, by using fewer components and materials, that will reduce construction costs, and that will provide for mobility and comfort for the user while allowing discreet wearability of the infusion set and pump.
Another object of the present invention is to provide an infusion set that can be primed prior to subcutaneous or intradermal injection of medicaments.
Another object of the present invention is to provide an infusion set that provides greater mobility for a user though a side port extension set that rotates up to 360 degrees around the injection site.
Another object of the present invention is to provide an infusion set that incorporates a multiple septum design and/or multiple septa for incorporation with such an infusion set.
Another object of the present invention is to provide an infusion set with a thin and/or rounded profile that allows the infusion set to be small and unobtrusive and which places the infusion set closer to the skin, and thus results in an infusion set that is more discreet when worn by a user.
These and other objects are substantially achieved by providing an exemplary infusion set that includes upper and lower septa within a base that can be surrounded by a septum cap with a plurality of access ports. A blunt cannula can be included with an extension set hub and can be configured to fit through one of the access ports of the septum cap and penetrate the interface between the upper septum and the lower septum to provide fluid communication from an infusion pump to the infusion set. However, to reduce the number of components in the device, the upper septum and the lower septum can be combined and/or replaced with a single septum. The septum cap can be rotatable on the base permitting the blunt cannula of the extension set to slide between the interface between the upper septum and the lower septum in a 360 degree manner along with the extension set hub as the septum cap is turned in a 360 degree manner.
The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the appended drawings, in which:
Throughout the drawings, like reference numerals will be understood to refer to like parts, components and structures.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTSAs will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements and arrangements of the infusion devices disclosed herein. Although reference will be made to the exemplary embodiments depicted in the drawings and the following descriptions, the embodiments disclosed herein are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed invention. The following description is provided in regard to a subcutaneous application of the invention, but embodiments are not limited thereto. Exemplary embodiments of the present invention can be applied equally to intradermal, intramuscular and subcutaneous applications.
An exemplary infusion device of the present invention is illustrated in
As shown in
As shown in greater detail in
As shown in
Further, when the upper septum 80 is pressed against the lower septum 90, a fluid seal is created at the annular area of contact between septa 80 and 90. However, as described in greater detail below, a blunt cannula of the extension set hub 30 can be inserted between the septa 80, 90 and can be rotated up to 360 degrees around the seal created at the area of contact between septa 80 and 90. The septum cap 70 includes at least one radial access port 130 configured to receive a blunt cannula of the extension set hub 30 in a motion parallel to the skin surface, and an axial access port 132 configured to receive an insertion needle in a motion perpendicular to the skin surface. Any of the above features can be molded as a single shot or as a rigid single shot and a flexible second shot.
Returning to
Referring to
Referring again to
As shown in
Once in position, the infusion set provides a rotatable connection to the infusion pump to thereby simplify the positioning of the infusion set, tubing and pump during use. Further, as the coupling and de-coupling movements of the extension set hub are performed using a motion substantially parallel to a skin surface, the placement of the infusion set is not affected and greater user comfort is provided. Still further, by using the interface between the upper septum and the lower septum as the access point for the blunt cannula, movement of the extension set hub in a 360 degree manner is permitted. However, to still further reduce the number of components in the device, the upper septum and the lower septum can be combined and/or replaced with a single septum.
For example,
The extension set hub 180 includes a ring-shaped guidance feature wall 220 protruding vertically from a snap ring 190. Similar to other embodiments of the present invention, the guidance feature wall 220 aids in aligning the sharp cannula 160 of the extension set hub 180 for insertion within one of the access ports 230 and to pierce a side wall of the single septum 170. This allows the user to receive medication from the infusion pump via a fluid path created from the infusion pump, through the extension set tubing, the extension set hub 180, the chamber 171 of the septum 170 and into the catheter. The septum 170 is configured to self-close the opening through which the sharp introducer needle 100 of the needle hub 20 has been removed, and the fluid path created by the penetration of the sharp cannula 160 through the septum 170 remains after the removal of the needle hub 20 and the sharp cannula needle 100 is pulled free of the septum 170.
The snap ring 190 flexes to allow enough deflection for the snap ring 190 to deflect around the septum cap 210 during insertion of the sharp cannula 160. This allows for a snap-fit engagement between the snap ring 190 and the septum cap 210. Molded-in, cut or otherwise provided hinges of the snap ring 190 are configured to flex to allow the snap ring 190 ring-shaped walls 220 to deflect around the septum cap during insertion of the sharp cannula 160 through the septum 170 according to an exemplary embodiment of the present invention. This allows for a snap-fit engagement between the snap ring 190 ring-shaped walls and the septum cap 70.
Once in position, coupling and de-coupling of the extension set hub and tubing is performed using a motion substantially parallel to the skin surface and at a user-selectable rotational position, such that the placement of the infusion set is not affected and greater user comfort is provided.
Further, the extension set hub and tubing can be easily primed before coupling with the septum cap and base. For example, before attaching the extension set hub 30 with the septum cap 70 as shown in
The needle hub, extension set hub, base and septum cap of each embodiment can be constructed of materials having a rigid, moldable property, such as thermoplastic elastomer (TPE), thermoplastic urethane (TPU) or similar material. In an exemplary embodiment, the base can be molded as a single shot, or as a rigid first shot and a flexible second shot. The upper, lower and single septa of each embodiment can be constructed of materials having a viscoelastic property, such as silicone.
Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention.
Claims
1. An infusion set, comprising:
- a base;
- an upper septum;
- a lower septum, said upper and lower septa together forming a substantially cylindrical hollow body having a chamber therein; and
- a septum cap, comprising a substantially cylindrical hollow body enclosing said upper and lower septa, wherein said septum cap comprises at least one radial port and at least one axial port.
2. The infusion set of claim 1, further comprising:
- an extension set hub; and
- a blunt cannula configured for insertion through said radial port and pass through an interface between said upper septum and said lower septum.
3. The extension set hub of claim 2, further comprising:
- a snap-ring comprising a substantially circular ring and a plurality of guidance walls flexibly extending therefrom.
4. The extension set hub of claim 3, wherein said plurality of guidance walls are configured to releasably secure an outer circumference of said septum cap.
5. The extension set hub of claim 3, wherein said plurality of guidance walls are configured to guide said blunt cannula through said radial port and through said interface between said upper septum and said lower septum.
6. The infusion set of claim 1, wherein said blunt cannula is configured to rotatably slide through said interface between said upper septum and said lower septum in a 360 degree manner.
7. The infusion set of claim 1, wherein said septum cap is configured to rotatably couple with said base.
8. A method of coupling an extension set hub comprising a blunt cannula, with an infusion set comprising a base, an upper septum, a lower septum, and a septum cap enclosing said upper and lower septa, said septum cap comprising at least one radial port and at least one axial port, the method comprising the steps of:
- affixing said base to a skin surface of a user;
- moving said extension set hub in a direction substantially parallel to said skin surface until said blunt cannula passes through said radial port and between said upper septum and said lower septum within said septum cap; and
- rotating said extension set hub in a 360 degree manner about said base until reaching a desired position.
9. The method of claim 8, wherein said extension set hub comprises a snap-ring, a substantially circular ring and a plurality of guidance walls extending therefrom, wherein said plurality of guidance walls are configured to releasably secure an outer circumference of said septum cap.
10. The method of claim 9, wherein said plurality of guidance walls are configured to guide said blunt cannula through said radial port and through said interface between said upper septum and said lower septum.
11. The method of claim 8, wherein said blunt cannula is configured to rotatably slide through said interface between said upper septum and said lower septum in a 360 degree manner.
12. The method of claim 8, wherein said septum cap is configured to rotatably couple with said base.
13. An infusion set, comprising:
- a base;
- a septum comprising a hollow body having a chamber therein; and
- a septum cap comprising a hollow body enclosing said septum, wherein said septum cap comprises at least one radial port and at least one axial port.
14. The infusion set of claim 13, further comprising:
- an extension set hub; and
- a cannula configured for insertion through said radial port.
15. The extension set hub of claim 14, further comprising:
- a snap-ring comprising a substantially circular ring and a plurality of guidance walls extending therefrom.
16. The extension set hub of claim 15, wherein said plurality of guidance walls are configured to releasably secure an outer circumference of said septum cap.
17. The extension set hub of claim 15, wherein said plurality of guidance walls are configured to guide said cannula through said radial port.
18. An infusion set, comprising:
- a base;
- at least one septum; and
- a septum cap enclosing said septum, wherein said septum cap comprises at least one radial port and at least one axial port.
19. The infusion set of claim 18, further comprising:
- an extension set hub; and
- a cannula, configured for insertion through said radial port.
20. The infusion set of claim 19, wherein said cannula comprises a blunt cannula, configured for insertion through said radial port and pass through an interface between an upper septum and a lower septum when said extension set hub is moved in a direction substantially parallel to said skin surface.
21. The infusion set of claim 20, wherein said blunt cannula is configured to rotatably slide through said interface between said upper septum and said lower septum in a 360 degree manner.
22. The infusion set of claim 19, wherein said cannula comprises a sharp cannula, configured for insertion through said radial port to pierce said septum when said extension set hub is moved in a direction substantially parallel to said skin surface.
Type: Application
Filed: Jul 16, 2013
Publication Date: Feb 6, 2014
Patent Grant number: 10220137
Applicant: Becton, Dickinson and Company (Franklin Lakes, NJ)
Inventor: Ralph L. Sonderegger (Farmington, UT)
Application Number: 13/943,365
International Classification: A61M 5/162 (20060101);